Events

Alerte De Sécurité sur Nexgen knee solution

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Zimmer Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1407-291
  • Numéro de l'événement
    2011DM-0007278
  • Date
    2014-07-17
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=200
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer informs that it has detected that it is possible that the clamping threads do not conform to the specifications, leading to the generation of possible adverse events on the patient.

Device

Nexgen knee solution
  • Modèle / numéro de série
    5950 with specific lots distributed between February 26, 2010 and May 15, 2014
  • Description du dispositif
    This device is indicated for patients with severe knee pain and disability due to: • rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Deogenous disorders, and / or vascular necrosis of the femoral condyle. • Post-traumatic loss of joint configuration, particularly when there is a patellofemoral erosion, dysfunction or previous patellectomy. • Moderate deformitiesvalue, varus or flexion. • The rescue of unsuccessful surgical attempts previously or for knee in which satisfactory stability can be obtained at the time of surgery.
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer Inc
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NIDFSINVIMA